Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
19/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Sarah Mills

ORCID ID

Contact details

North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
Harrow
Middlesex
HA1 3UJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0515088426

Study information

Scientific title

Does peri-operative enteral nutrition and immunonutrition alter immunological response to surgery, improve blood supply to the gut and improve clinical outcome of patients undergoing restorative proctocolectomy?

Acronym

Study hypothesis

Improved peri-operative enteral nutrition and immunonutrition beneficially alter the patient's immunological response to the insult of major pelvic surgery. Restorative proctocolectomy for ulcerative colitis is undertaken for two reasons, either because of the failure of medical management to control symptoms and dependence on immune suppressants or the risk of developing adenocarcinoma following many years of ulcerative colitis. Patients electing to undergo restorative proctocolectomy have therefore been suffering from a chronic disease that effects their nutritional and immune state, leading to higher rates of post operative complications including sepsis, leading to a significant increase in morbidity and hospital stay. Unfortunately, around 10% of ileoanal pouches fail and require excision the majority of these in the first 2 years due to pelvic sepsis. This trial will compare surrogate markers of immune modulation and clinical complications in fed and unfed groups to assess the benefit of peri-operative enteral nutrition.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Surgery: Restorative proctocolectomy

Intervention

Patients will be assigned to one of three groups:
Group 1 will receive normal pre-operative and post-operative care with no supplemental nutrition.
Group 2 will receive one week pre-operative supplemental enteral nutrition isocalorific and isonitrogenous to IMPACT to provide 25 Kcal/kg/day.
Group 3 will receive one week pre-operative supplemental enteral nutrition with IMPACT to provide 25 Kcal/kg/day.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Peripheral blood leukocyte subsets will be tested for intracellular pro-inflammatory cytokines InterLeukin-6 (IL-6), InterLeukin-2 (IL-2) and anti-inflammatory cytokine InterLeukin-10 (IL-10) using the technique of Carrock Sewell et al 1997. Phagocyte activity of both granulocytes and monocytes will be tested directly using fluroescein labeled opsonised bacteria. Blood will be taken prior to feeding, preoperatively, intraoperatively and on postoperative days three and seven. At laparotomy a biopsy of small bowel mucosa will be taken to assess leukocyte subsets for intracellular pro-inflammatory cytokines IL-6, IL-2 and anti-inflammatory cytokine IL-10. Phagocyte activity of both granulocytes will be tested directly using fluorescein labeled opsonised bacteria. Two further biopsies will be taken on days three and seven postoperatively for correlation with the peripheral blood immunology.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2000

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

30 patients aged between 18-65 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/11/2000

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North West London Hospitals NHS Trust
Harrow, Middlesex
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

North West London Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/09/2016: No publications found, verifying study status with principal investigator.